Plication Lock Delivery System and Method of Use Thereof

ABSTRACT

A plication lock delivery system that enables a suture lock assembly to be delivered percutaneouly. The plication lock delivery system comprises a lock assembly that secures sutures in place, a control assembly that allows a clinician to engage a suture to a suture lock assembly, apply tension to the sutures to cause tissue plication, and deploy the lock assembly, and a catheter assembly. This plication lock delivery system can be used to repair mitral regurgitation percutaneouly or in an open-heart surgery.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/039,779, filed Sep. 27, 2013, which claims priority to U.S.patent application Ser. No. 61/707,940, filed Sep. 29, 2012, which areincorporated by reference as if expressly set forth in their respectiveentireties herein.

TECHNICAL FIELD

The present teachings generally relate to lock assemblies, for example,used in catheter-based surgical procedures. The present teachings alsorelate to plication lock delivery systems and methods of using suchplication lock delivery systems to deliver and deploy a lock assembly ofthe present teachings to, for example, secure one or more tensioningmembers.

BACKGROUND

Catheter-based surgical procedures can be used to repair tissues, suchas a defective mitral valve. One such catheter-based surgical procedure,commonly referred to as annuloplasty, reduces the length of a posteriormitral valve leaflet through one or more plications. Specifically,anchors are secured at a plurality of locations distributed around theannulus near the posterior leaflet of a mitral valve. Each anchor has asuture coupled thereto. The sutures are collectively gathered and pulledtight. As the sutures are pulled, the tissue between each pair ofadjacent anchors is plicated, thereby shortening the length of theannulus and drawing the posterior leaflet toward the anterior leaflet.

During a surgical procedure, the sutures for each of the anchors extendto an incision site through a catheter. To preserve the plications, thesutures must be secured against movement. Because the procedures arecatheter-based, suture locks are typically used because of the smalldiameter of the catheter.

There is generally a need for an improved lock to secure one or moretensioning members, such as sutures, against relative movement duringand after a catheter-based surgical procedure and an improved plicationlock delivery system to deliver the improved lock.

SUMMARY

One aspect of the present teachings provides a lock delivery system fordelivering a lock assembly percutaneously. In various embodiments, alock delivery system comprises a lock assembly. In some embodiments, thelock assembly is configured to secure at least one suture. In variousembodiments, a lock delivery system comprises a catheter assembly. Insome embodiments, the catheter assembly comprises a distal end and aproximal end, wherein the distal end of the catheter assembly isconfigured to connect the lock assembly. In various embodiments, a lockdelivery system comprises a control assembly. In some embodiments, thecontrol assembly is configured to connect the proximal end of thecatheter assembly. In some embodiments, the control assembly isconfigured to apply tension to at least one suture. In some embodiments,the control assembly is configured to activate the securing of at leastone suture to the lock assembly. In some embodiments, the controlassembly is configured to release the lock assembly.

Another aspect of the present teachings provides a plication lockdelivery system, for example, for creating a tissue plication. Invarious embodiments, a plication lock delivery system comprises a lockassembly. In some embodiment, the lock assembly comprises a lock bodyand a lock pin. In certain embodiments, the lock body has a centrallumen configured to retain the lock pin and to have at least two suturesdisposed within the central lumen. In various embodiments, a plicationlock delivery system further comprises a catheter assembly. In someembodiments, the catheter assembly comprises an outer sheath and aninner catheter. In certain embodiments, the inner catheter has a distalend, a proximal end, and a central lumen. In particular embodiments, thedistal end of the inner catheter is configured to connect the lock body.In particular embodiments, the central lumen of an inner catheter isconfigured to have the two sutures disposed within. In particularembodiments, the outer sheath of a catheter assembly has a distal endand a proximal end. In particular embodiments, the distal end of anouter sheath is configured to contact the lock pin. In variousembodiments, a plication lock delivery system also comprises a controlassembly. In some embodiments, the control assembly comprises a firstsuture tension mechanism configured to apply tension to one suture. Insome embodiments, the control assembly comprises a second suture tensionmechanism configured to apply tension to the second suture. In someembodiments, the control assembly comprises a lock deploy-and-releasemechanism configured to secure the two sutures to the lock assembly andto release the lock assembly inside the body. In some embodiments, thecontrol assembly connects the proximal ends of the outer sheath andinner catheter.

Another aspect of the present teachings provides a control assembly of aplication lock delivery system. In various embodiments, a controlassembly comprises a housing that includes at least one of a suturetension mechanism, a tissue plication mechanism, and a lockdeploy-and-release mechanism. In some embodiments, a suture tensionmechanism is configured to secure and apply tension to one suture. Insome embodiments, a tissue plication mechanism is configured to secureand apply tension to another suture. In some embodiments, a lockdeploy-and-release mechanism is configured to secure the two sutures toa lock assembly and to release the lock assembly from the controlassembly.

Another aspect of the present teachings provides a method of deliveringa lock assembly percutaneusly. In various embodiments, the methodincludes providing a lock delivery system with a lock assembly, acatheter assembly comprising a distal end and a proximal end, and acontrol assembly. In some embodiment, the lock assembly is configured tosecure at least one suture. In other embodiments, the distal end of thecatheter assembly is configured to connect the lock assembly, and thecontrol assembly is configured to connect the proximal end of thecatheter assembly, to apply tension to the at least one suture, toactivate the securing of the suture to the lock assembly, and to releasethe lock assembly. In other embodiments, the method further includesextending the at least one suture through the lock assembly, extendingthe at least one suture from the distal end to the proximal end of thecatheter assembly, joining the at least one suture to the controlassembly, applying tension to the at least one suture, secure thetensioned suture to the lock assembly, and releasing the lock assemblyfrom the catheter assembly.

Another aspect of the present teachings provides a method of plicating atissue and securing the tissue plication with a lock assemblypercutaneusly. In various embodiment, the method comprises providing aplication lock delivery system of the present teachings, for example,including a lock assembly, a catheter assembly comprising an outersheath and an inner catheter, and a control assembly. In someembodiments, the lock assembly comprises a lock body and a lock pin,wherein the lock body has a central lumen configured to retain the lockpin and have two sutures disposed within. In other embodiments, theinner catheter has a distal end, a proximal end, and a central lumen,wherein the distal end of the inner catheter is configured to connectthe lock body, and the central lumen is configured to have the twosutures disposed within, and the outer sheath has a distal endconfigured to contact the lock pin and a proximal end. In yet otherembodiments, the control assembly connects the proximal ends of theouter sheath and inner catheter and comprises a first suture tensionmechanism configured to apply tension to one suture, a second suturetension mechanism configured to apply tension to another suture, and alock deploy-and-release mechanism configured to secure the two suturesto the lock assembly and to release the lock assembly inside the body.In yet other embodiments, the method further comprises extending the twosutures through the lock assembly. In yet other embodiments, the methodfurther comprises extending the two sutures from the distal end to theproximal end of the catheter assembly. In yet other embodiments, themethod further comprises applying tension to one suture with the firstsuture tension mechanism of the control assembly. In yet otherembodiments, the method further comprises applying tension to theanother suture with the second suture tension mechanism of the controlassembly. In yet other embodiments, the method further comprisessecuring the two sutures to the lock assembly with the lockdeploy-and-release mechanism of the control assembly. In yet otherembodiments, the method further comprises releasing said lock assemblyfrom the catheter assembly.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a perspective view of two exemplary pledgets deployed at amitral valve annulus in accordance with the present teachings;

FIG. 2a is a perspective view of an exemplary lock assembly inaccordance with the present teachings;

FIG. 2b is a perspective cross-section of an exemplary lock assembly inaccordance with the present teachings;

FIG. 3a is a sectional view of an exemplary catheter assembly inaccordance with the present teachings;

FIG. 3b is a cross-sectional view of an exemplary inner catheter inaccordance with the present teachings;

FIGS. 4a and 4b are top plan views of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 5a is a side perspective view of an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 5b is a cross-sectional view of an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 6a is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 6b is a side elevation view of an exemplary plication lock deliverysystem in accordance with the present teachings;

FIG. 7a is a side elevation view, in partial breakaway, of a suturethreader in accordance with the present teachings;

FIG. 7b is a cross-sectional view of an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 8a is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 8b is a cross-sectional view of an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 9a is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 9b is a partial cross-sectional view of two exemplary pledgetsdeployed at a mitral valve annulus, and an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 9c is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 9d is a cross-sectional view of an exemplary tissue plication andan exemplary plication lock delivery system in accordance with thepresent teachings;

FIG. 10a is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings;

FIG. 10b is a cross-sectional view of an exemplary plication lockdelivery system in accordance with the present teachings;

FIG. 10c is a top plan view, in partial breakaway, of an exemplarycontrol assembly of a plication lock delivery system in accordance withthe present teachings;

FIG. 11a is a cross-sectional view of an exemplary plication lockdelivery system in accordance with the present teachings.

FIG. 11b is a top plan view of an exemplary control assembly of aplication lock delivery system in accordance with the present teachings.

FIG. 12 is an exploded perspective view of an exemplary control assemblyof a plication lock delivery system in accordance with the presentteachings; and

FIG. 13 is a perspective view of an exemplary pull wire clasp assemblyin accordance with the present teachings.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Certain specific details are set forth in the following description andFigures to provide an understanding of various embodiments of thepresent teachings. Those of ordinary skill in the relevant art willunderstand that they can practice other embodiments of the presentteachings without one or more of the details described below. Thus, itis not the intention of the Applicants to restrict or in any way limitthe scope of the appended claims to such details. While variousprocesses are described with reference to steps and sequences in thefollowing disclosure, the steps and sequences of steps should not betaken as required to practice all embodiments of the present teachings.

As used herein, the terms “subject” and “patient” refer to an animal,such as a mammal, such as a livestock, a pet, and, preferably, a human.Specific examples of “subjects” and “patients” include, but are notlimited to, individuals requiring medical assistance and, in particular,requiring treatment for heart failure or valve dysfunction.

As used herein, the term “lumen” means a canal, duct, generally tubularspace or cavity in the body of a subject, including veins, arteries,blood vessels, capillaries, intestines, and the like.

As used herein, the term “proximal” means closest to the operator (lessinto the body) and “distal” shall mean furthest from the operator(further into the body). In positioning a medical device from adownstream access point, distal is more upstream and proximal is moredownstream.

As used herein, the term “suture” means a tensioning member which cantake forms other than a suture material, such as a cable or any othersmall diameter, flexible, semi-rigid or rigid material having a suitablyhigh tensile strength for the intended use. It will be readilyappreciated that while the embodiments of the present teachings asdescribed herein sometimes refer to as a suture lock, the presentteachings contemplate that the suture lock can also be used withtensioning members other than sutures.

As used herein, the term “wire” can be a strand, a cord, a fiber, ayarn, a filament, a cable, a thread, or the like, and these terms may beused interchangeably.

Unless otherwise specified, all numbers expressing quantities,measurements, and other properties or parameters used herein are to beunderstood as being modified in all instances by the term “about.”Accordingly, unless otherwise indicated, it should be understood thatthe numerical parameters set forth in the following specification andattached claims are approximations. At the very least, and not as anattempt to limit the application of the doctrine of equivalents to thescope of the claims, numerical parameters should be read in light of thenumber of reported significant digits and the application of ordinaryrounding techniques.

The present teachings provide a plication lock delivery system (100).For example, a plication lock delivery system can be used to deliver asuture lock device or assembly (20), for example, percutaneouly, into apatient's body where tension can be applied to a suture by the deliverysystem, causing tissue plication. In some embodiments, the lock assembly(20) secures the sutures in place.

Various embodiments of the present teachings include a control device orassembly (60). In some embodiments, the control assembly allows aclinician to engage a suture to a suture lock assembly (20). In someembodiments, the control assembly allows a clinician to apply tension tothe suture to cause tissue plication. In some embodiments, the controlassembly allows a clinician to deploy the lock assembly (20). In someembodiments, a clinician conducts at least one of these stepspercutaneously. In other embodiments, a clinician conducts at least oneof these steps in other minimally invasive approaches or in anopen-heart surgery. In various embodiments, the tissue is a mitral valveannulus.

The present teachings also provide a plication lock delivery system. Invarious embodiments, the plication lock delivery system (100) includesthe control assembly (60). In various embodiments, the plication lockdelivery system (100) further comprises a catheter assembly (40).

As illustrated in FIG. 1, in various embodiments, two pledgets (12, 14)deployed on a mitral valve annulus (10) with one suture extending fromeach pledget (12, 14) to the outside of the patient body. For ease ofexplanation, the term “two sutures” will be used hereinafter, althoughit should be understood that the term “two sutures” can refer to twoends of the same suture, or two ends of two sutures with the other twoends connected to each other, or two separate sutures. Although pledgets(12, 14) are used to exemplify the present teachings, one skilled in theart should understand that tissue anchors with other shapes, sizes,designs, and materials can also be used. Specifically, tissue anchorsembodiments are described in U.S. Pat. No. 6,718,985, entitled “Methodand apparatus for catheter-based annuloplasty using local plications,”filed May 25, 2001; U.S. Pat. No. 7,037,334, entitled “Method andapparatus for catheter-based annuloplasty using local plications,” filedJul. 18, 2003; U.S. Pat. No. 7,166,127, entitled “Tissue fasteningsystem and methods utilizing magnetic guidance,” filed Sep. 24, 2004;U.S. Pat. No. 7,431,726, entitled “Tissue fastening system and methodsutilizing magnetic guidance,” filed Sep. 24, 2004; U.S. Pat. No.8,142,493, entitled “Method of heart valve repair,” filed Jul. 22, 2008;U.S. Pat. No. 8,202,315, entitled “Catheter-based annuloplasty usingventricularly positioned catheter,” filed Aug. 2, 2010; U.S. patentapplication Ser. No. 10/689,872, entitled “Method and apparatus forcatheter-based annuloplasty using local plications,” filed Oct. 21,2003; U.S. patent application Ser. No. 10/948,923, entitled “Tissuefastening systems and methods utilizing magnetic guidance,” filed Sep.24, 2004; U.S. patent application Ser. No. 11/174,951, entitled “Tissueanchor, anchoring system and methods of using the same,” filed Jul. 5,2005; U.S. patent application Ser. No. 11/685,239, entitled “Systems andmethods for introducing elements into tissue,” filed Mar. 13, 2007; U.S.patent application Ser. No. 11/685,240, entitled “Tissue anchor,anchoring system and methods, and devices,” filed Mar. 13, 2007; U.S.patent application Ser. No. 11/685,242, entitled “Devices and methodsfor introducing elements into tissue,” filed Mar. 13, 2007; U.S. patentapplication Ser. No. 12/273,670, entitled “Tissue anchor and anchoringsystem,” filed Nov. 19, 2008; and U.S. patent application Ser. No.12/557,655, entitled “Tissue plication device and method for its use,”filed Sep. 11, 2009. Each of the above mentioned patents and patentapplications is incorporated herein by reference in its entirety.

According to various embodiments of the present teachings, a tissueplication and lock procedure starts by conditioning a plication lockdelivery system (100), which can include the lock assembly (20), thecatheter structure or assembly (40), and the control assembly (60), intoa pre-load configuration. For example, in the pre-load configuration, acatheter assembly (40) engages the lock assembly (20) at its distal end(42) and connects to the control assembly (60) at its proximal end (44);an inner catheter (46) of the catheter assembly (40) is compressed by anouter sheath (48); and the outer sheath (48) is in tension by the innercatheter (46). Without being limited to any specific theory, thepre-load configuration can prevent the inner catheter (46) fromdeforming when advancing inside a body. In some embodiments, two sutures(16, 18) are captured by a suture threader (102) (FIG. 7a ) and threadedinto the plication lock delivery system (100); the two sutures (16, 18)extend from the distal end (22) of the lock assembly (20) and throughthe longitudinal lumen (26) of the lock assembly (20) and the catheterassembly (40), and exit from a suture port (62) on the control assembly(60). In some embodiments, the plication lock delivery system (100) isinserted into the body and tracked over the two sutures (16, 18)distally toward the pledgets (12, 14). In some embodiments, a tissueplication starts by engaging one suture to a suture tension mechanism(64) on the control assembly (60) and applying tension to the suture.Doing so can, for example, align the lock assembly (20) with the pledgetwhere the suture extends from. In some embodiments, the second suture isengaged to the tissue plication mechanism (68). Upon applying tension tothis second suture, the two pledgets (12, 14) can be pulled closer toeach other. In some embodiments, while maintaining tension on thesutures (16, 18), the lock assembly (20) is deployed, thereby securingthe sutures (16, 18) in a tensioned state. In some embodiments, thecontrol assembly (60) is then used to release the lock assembly (20)from the catheter assembly (40), removing the plication lock deliverysystem (100) entirely from the body and leaving the lock assembly (20)to secure the tissue plication. In some embodiments, a suture cutter(not shown) can then be advanced to a proximity to the lock assembly(20) and be used to remove the excess suture. Both the suture cutter andthe severed sutures can then be removed completely from the patient.

FIGS. 2a-b illustrate the exemplary lock assembly (20) according tovarious embodiments of the present teachings. As illustrated in FIG. 2a, the exemplary lock assembly (20) includes a lock body (30) and a lockpin (32); the lock body (30) has an elongated body with a distal end(22), a proximal end (24) and a longitudinal lumen (26) extending fromthe distal end (22) to the proximal end (24) parallel to thelongitudinal axis of the lock body (30), and the longitudinal lumen (26)includes a distal opening (34) and a proximal opening (36). In variousembodiments of the present teachings, the longitudinal lumen (26) has ageneral width of about 1-3 mm and the lock body (30) has a generallength of about 3-10 mm and a general outside diameter of about 2-5 mm.In some embodiments of the present teachings, the distal opening (34) issmaller than the proximal opening (36). In other embodiments of thepresent teachings, the distal opening (34) has a same size as theproximal opening (36). In yet other embodiments of the presentteachings, the distal opening (34) is greater than the proximal opening(36). One skilled in the art should understand that the sizes of theopenings (34, 36) at the distal and proximal ends (22, 24) of the lockbody (30) vary according to the size, shape, material of the mitralvalve annulus implant.

Continuously referring to FIG. 2a , the exemplary lock body (30)includes a tubular surface (28) and a slot (38) extending from one sideof the tubular surface (28) to the opposite side of the tubular surface(28), intersecting the longitudinal lumen (26). As shown in FIG. 2a ,the slot (38) is angled or curved against the longitudinal axis of thelock body (30) and extends from the distal end (22) to the proximal end(24). In some embodiments, the distal end of the slot is adjacent to thedistal end (22) of the lock body (30). In some embodiments, the proximalend of the slot is adjacent to the proximal end (24) of the lock body(30). In certain embodiments, the slot (38) is configured to retain thelock pin (32).

As seen in FIG. 2a , the lock pin (32) is slidably disposed within theslot 38 on the exemplary lock body (30). In some embodiments, the lockpin (32) has a general elongated body with a center portion and twoends, each of which is narrower than the center portion (i.e., taperedends). In certain embodiments, when the lock pin (32) is retained by theslot 38, the center portion is trapped inside the intersection formed bythe slot (38) and the longitudinal lumen (26), and two narrower ends ofthe lock pin (32) extend laterally outside of the tubular surface (28)of the lock body (30). In particular embodiments, the lock pin (32) hasa general length of 2-5 mm, with the center portion having a diameter of0.5-2 mm and the ends each having a diameter of 0.25-1 mm.

According to various embodiments, without engaging sutures inside thelock assembly (20), the lock pin (32) slides freely from one end to theother end of the slot (38). In these embodiments, because the slot iscurved or angled against the longitudinal axis of the lock body (30), asthe lock pin (32) sliding from one end to the other end of the slot(38), the space between one side of the lock pin (32) to the inner lumenwall of the lock body (30) gradually changes. According to someembodiments of the present teachings, for example as illustrated in FIG.8b , two sutures (16, 18) extend through the longitudinal lumen (26) ofthe lock body (30) and are positioned on one side of the lock pin (32).In certain embodiments, when the lock pin (32) is positioned at theproximal end of the slot (38), the space (39) where the sutures (16, 18)taken up between the lock pin (32) to the inner lumen wall of the lockbody (30) is the greatest. In certain embodiments, when the lock ispositioned at the distal end of the slot (38), the space (39) where thesutures (16, 18) taken up between the lock pin (32) to the inner lumenwall of the lock body (30) is the smallest. In certain embodiments, asthe lock pin (32) slides from the proximal end to the distal end of theslot (38), the space (39) where the sutures (16, 18) taken up betweenthe lock pin (32) and the inner lumen wall of the lock body (30) isreduced. In certain embodiments, as the lock pin (32) reaches a certainplace in the slot (38), the sutures (16, 18) are compressed between thelock pin (32) and the lock body (30), which prevents the sutures (16,18) from moving.

According to various embodiments of the present teachings, the crosssection of a lock body (30) and/or a lock pin (32) may be circular orpolygonal, such as square or hexagonal. Although the lock body (30)disclosed above is a single component in various embodiments, it shouldbe understood by those skilled in the art that the lock body (30) devicemay be fabricated as a two-piece (or multi-piece) component and the two(or multiple) components are connected to form the entire lock assembly(20). For example, in order to assemble the lock pin (32) inside thelock body (30), the lock body (30) can have a top cap and a bottom bodyso that the cap and body can be joined together after the lock pin (32)is inserted. It should be understood by those skilled in the art thatcertain design features of the lock body (30) can be modified for easeof assembling with the lock pin (32). For example, the distal end of theslot (38) can have a larger side opening (37), allowing the centerportion of the lock pin (32) to slide through.

In some embodiments of the present teachings, a lock body (30) can befabricated by laser-cutting or acid-etching a pattern into a preformedtube. In other embodiments, a lock body (30) can be formed from a hollowtube that has been slotted, for example, by using a machining laser,EDM, or other methods, and then expanded to form an open structure.

Now referring to FIG. 2b , the exemplary lock body (30) can furtherinclude a side opening (37) extending from the tubular surface (28) ofthe lock body (30) to the longitudinal lumen (26) and a blind hole (35)extending from the proximal end (24) of the lock body (30) andintersecting and passing through and beyond the side opening (37). Invarious embodiments of the present teachings, the side opening (37) onthe tubular surface is close to the proximal end (24) of the lock body(30). In some embodiments, the side opening (37) is perpendicular to thelongitudinal axis of the lock body (30). In some embodiments, the sideopening (37) is angled to the longitudinal axis of the lock body (30).In some embodiments, the blind hold (35) is parallel to the longitudinalaxis of the lock body (30). In some embodiments, the blind hole (35) isnot parallel to the longitudinal axis or the longitudinal lumen (26) ofthe lock body (30). In some embodiments of the present teachings, thedistal end of the blind hole (35) is distal to its intersection to theside opening (37). The blind hole (35) can be configured to receive apost (43) on the distal end (42) of the inner catheter (46) as explainedin detail herein. The side opening (37) can be configured to receive apull wire (50) including a loop (52) thereof as described herein. Insome embodiments of the present teachings, the side opening (37) has ageneral height of 0.25-1 mm and a length of 0.5-2 mm. In someembodiments, the blind hole (35) has a general diameter of 0.25-1 mm anda length of 1-3 mm.

In various embodiments of the present teachings, one or both of the lockbody (30) and the lock pin (32) are made of a biocompatible metal, suchas stainless steel, nitinol, Titanium, Elgiloy, Vitalium, Mobilium,Ticonium, Platinore, Stellite, Tantalum, Platium, Hastelloy, CoCrNialloys (e.g., trade name Phynox), MP35N, or CoCrMo alloys or othermetallic alloys. In other embodiments of the present teachings, one orboth of the lock body (30) and the lock pin (32) are made of abiocompatible polymer, such as PTFE, UHMPE, HDPE, polypropylene,polysulfone, a mixture thereof, or other biocompatible plasticmaterials. In some embodiments where the lock body (30) and/or the lockpin (32) is made of a biocompatible polymer, a radioopaque marker isalso used to assist visualization, for example, fluoroscopically. Inother embodiments of the present teachings, the surface finish of thelock body (30) is textured to induce tissue response and tissuein-growth for improved stabilization.

FIG. 3a illustrates an embodiment of the distal end portion (42) of acatheter assembly (40) of the present teachings. In some embodiments,the catheter assembly (40) has a distal end portion (42) as illustratedand a proximal end portion (not shown) connecting to a control assembly(60). In some embodiments, the catheter assembly (40) includes an outersheath (48), an inner catheter (46), and a pull wire (50). In someembodiments, the outer sheath (48) of the catheter assembly (40) has aproximal end (not shown) connecting to the control assembly (60), adistal end (49) configured to push a lock pin (32) distally, and anelongated lumen (47) extending along the longitudinal axis of the outersheath (48) from the distal end (49) to the proximal end (not shown) Asshown, the inner catheter (46) is located within the interior of theouter catheter (48) and does not extend distally beyond in thisposition. In some embodiments, the inner catheter (46) is slidablydisposed within the elongated lumen (47) of the outer sheath (48). Insome embodiments, the inner catheter (46) also has a distal end (45)configured to contact the proximal end (24) of the lock body (30), aproximal end (not shown) connecting to the control assembly (60), and atleast one elongated lumen extending along the longitudinal axis of theinner catheter (46) from the distal end (45) to the proximal end (notshown). In some embodiments, the distal end (45) of the inner catheter(46) has a distal post (43) extending distally and is configured toslide inside the blind hole (35) on the lock body (30). In someembodiments, the pull wire (50) is slidably disposed within the innercatheter lumen. In some embodiments, the pull wire (50) includes a wireloop (52) at a distal end and is configured to extend through the sideopening (37) on the lock body (30). In some embodiments, the pull wire(50) connects to a lock deploy-and-release mechanism (70) on the controlassembly (60). According to some embodiments of the present teachings,the pull wire (50) is an elongated wire with a loop formed at its distalend. In other embodiments of the present teachings, the pull wire (50)is an elongated hypotube with the wire loop (52) disposed at a distalend of the hypotube.

In various embodiments of the present teachings, the pull wire (50) orthe distal loop (52) of the pull wire (50) is constructed from asuture-like material. However, the construction or the materials shouldnot be considered limiting and alternative embodiments include thosedescribed in details herein. According to some embodiments, the wireused to form the pull wire (50) or the distal loop (52) of the pull wire(50) has a general diameter from about 0.02 mm to about 1 mm. In someembodiments of the present teachings, the pull wire (50) is made of abiocompatible metal including stainless steel, nitinol, Titanium,Elgiloy, Vitalium, Mobilium, Ticonium, Platinore, Stellite, Tantalum,Platium, Hastelloy, CoCrNi alloys (e.g., trade name Phynox), MP35N, orCoCrMo alloys or other metallic alloys. In other embodiments, the pullwire (50) is made of a biocompatible polymer including PTFE, UHMPE,HDPE, polypropylene, polysulfone, and mixture thereof.

In various embodiments of the present teachings, after sliding throughthe lock assembly (20), two sutures (16, 18) are inserted, extendingfrom the distal end (45) of the inner catheter (46) proximally, exitingthe proximal end (not shown) of the inner catheter (46), and reaching asuture port (62) on the control assembly (60). According to someembodiments of the present teachings, the inner catheter (46) includesan elongated lumen when both the pull wire (50) and sutures (16, 18) areslidably disposed within. In other embodiments of the present teachings,as a cross-section view illustrated in FIG. 3b , the inner catheter (46)includes two elongated lumens (53, 54) side by side, either parallel orunparallel to each other, where two sutures (16, 18) are slidablydisposed within one lumen (54), and a pull wire (50) is slidablydisposed within the other (53). Yet in other embodiments, the innercatheter (46) includes three elongated lumens side by side, eitherparallel or unparallel to one other, where each of the suture isslidably disposed within one lumen and a pull wire (50) is slidablydisposed within the other. In yet other embodiments, the inner catheter(46) includes more than three elongated lumens.

According to various embodiments of the present teachings, the lockassembly (20) is configured to be slidably disposed within the distalend portion of the outer sheath (48) in part or in whole, and the outersheath (48) is configured to push on the two narrow ends of the lock pin(32) extending outside of tubular surface of the lock body (30). Asshown in FIG. 3a , in an exemplary embodiment, the distal end (49) ofthe outer sheath (48) also includes at least one slot (55) eachextending from the distal end (49) of the outer sheath (48) proximallyand the slots are disposed across one other and extend along thelongitudinal axis of the outer sheath (48). The slots (55) are thusformed along an inner surface of the outer sheath (48). In someembodiments, the slot (55) on the outer sheath (48) match the slot (38)on the lock body (30) so that as the lock assembly (20) slides withinthe elongated lumen (47) of the outer sheath (48), the narrow ends ofthe lock pin (32) slide within the slot (55) on the outer sheath (48).In some embodiments when the outer sheath (48) extends distally relativeto the lock assembly (20), the lock pin (32) is pushed distally by thedistal end (49) of the outer sheath (48) and slides along the slot (38)on the lock body (30) distally. Alternatively, in some embodiments wherethe lock assembly (20) is pulled proximally relative to the outer sheath(48), the lock pin (32) is pushed distally by the distal end (49) of theouter sheath (48) along the slot (38) on the lock body (30). One skilledin the art would appreciate that other design configurations could alsobe incorporated to achieve the same function or obvious variationsthereof. For example, the outer sheath (48) can have a flat distal end(49).

In various embodiments of the present teachings, the outer sheath (48)and the inner catheter (46) can be formed from a variety of materials.Typical materials used to construct the catheters and/or the sheaths ofthe present teachings can comprise commonly known materials such asAmorphous Commodity Thermoplastics that include Polymethyl Methacrylate(PMMA or Acrylic), Polystyrene (PS), Acrylonitrile Butadiene Styrene(ABS), Polyvinyl Chloride (PVC), Modified Polyethylene TerephthalateGlycol (PETG), Cellulose Acetate Butyrate (CAB); Semi-CrystallineCommodity Plastics that include Polyethylene (PE), High DensityPolyethylene (HDPE), Low Density Polyethylene (LDPE or LLDPE),Polypropylene (PP), Polymethylpentene (PMP); Amorphous EngineeringThermoplastics that include Polycarbonate (PC), Polyphenylene Oxide(PPO), Modified Polyphenylene Oxide (Mod PPO), Polyphenelyne Ether(PPE), Modified Polyphenelyne Ether (Mod PPE), Polyurethane (PU),Thermoplastic Polyurethane (TPU); Semi-Crystalline EngineeringThermoplastics that include Polyamide (PA or Nylon), Polyoxymethylene(POM or Acetal), Polyethylene Terephthalate (PET, ThermoplasticPolyester), Polybutylene Terephthalate (PBT, Thermoplastic Polyester),Ultra High Molecular Weight Polyethylene (UHMW-PE); High PerformanceThermoplastics that include Polyimide (PI, Imidized Plastic), PolyamideImide (PAI, Imidized Plastic), Polybenzimidazole (PBI, ImidizedPlastic); Amorphous High Performance Thermoplastics that includePolysulfone (PSU), Polyetherimide (PEI), Polyether Sulfone (PES),Polyaryl Sulfone (PAS); Semi-Crystalline High Performance Thermoplasticsthat include Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK);and Semi-Crystalline High Performance Thermoplastics, Fluoropolymersthat include Fluorinated Ethylene Propylene (FEP), EthyleneChlorotrifluroethylene (ECTFE), Ethylene, Ethylene Tetrafluoroethylene(ETFE), Polychlortrifluoroethylene (PCTFE), Polytetrafluoroethylene(PTFE), Expanded Polytetrafluoroethylene (ePTFE), PolyvinylideneFluoride (PVDF), Perfluoroalkoxy (PFA). Other commonly known medicalgrade materials that can be used in embodiments of the present teachingsinclude elastomeric organosilicon polymers, polyether block amide orthermoplastic copolyether (PEBAX), Kevlar, and metals such as stainlesssteel and nickel/titanium (nitinol) alloys. In other embodiments, theouter sheath (48) and inner catheter (46) includes at least oneradioopaque marker element. In some embodiments, the radioopaque markeris near the distal end of the outer sheath (48) and the inner catheter(46). In some embodiments, the radioopaque marker elements are made of ametal or a metal alloy, such as, for example, one or more of nitinol,Elgiloy®, Phynox®, MP35N, stainless steel, nickel, titanium, gold,rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium,hafnium, and alloys thereof.

In various embodiments, the outer sheath (48) and inner catheter (46)have a general diameter of 2.5-5 mm and 2-4.5 mm respectively.

FIGS. 4a and 4b illustrate an exemplary control assembly (60). Invarious embodiments, the control assembly (60) has a housing (61),holding various control mechanisms, and a suture port (62) on thecontrol assembly (60), allowing a suture threader (102) and sutures (16,18) extending in and out of a plication lock delivery system (100). Invarious embodiments, a first suture clamp (63) secures one suture, whileallowing the suture tension mechanism (64) to apply tension to thesuture. In various embodiments, a second suture clamp (67) secures theother suture, while allowing the tissue plication mechanism (68) toapply tension to the suture and plicate the tissue. In some embodiments,a lock deploy-and-release mechanism (70) deploys the lock assembly (20)to secure tissue plication and releases the lock assembly (20). In someembodiments of the present teachings, the lock deploy-and-releasemechanism (70) also includes an indicator (72) to guide a clinicianduring the lock assembly (20) deployment and releasing steps. In certainembodiments, as illustrated in FIG. 4, an exemplary control assembly(60) also includes a pre-load cam (66) as described herein.

FIG. 5a illustrates an exemplary plication lock delivery system (100) ofthe present teachings, where a lock assembly (20), a catheter assembly(40) and a control assembly (60) are assembled in accordance withvarious embodiments of the present teachings. As shown in FIG. 5b (across-section view of the distal end portion of the plication lockdelivery system (100) with a suture threader disposed within), thedistal loop (52) of a pull wire (50) extends across a side opening (37)on the exemplary lock assembly (20), and a distal post (43) on an innercatheter (46) of the exemplary catheter assembly (40) slides across thedistal loop of the pull wire (50) and enters a blind hole (35) on thelock body (30). In some embodiments, upon pulling the pull wire (50)proximally, the lock assembly (20) and the inner catheter (46) arejoined together with the distal end (45) of the inner catheter (46)contacting the proximal end (24) of the lock body (30); the outer sheath(48) slides over the lock assembly (20) and inner catheter (46), and thedistal end portion of the outer sheath (48) covers the distal end (45)of the inner catheter (46) and at least some proximal portion of thelock assembly (20). In certain embodiments, the catheter assembly (40)is further joined to the control assembly (60), for example, the pullwire (50) joined to the lock deploy-and-release mechanism (70) on thecontrol assembly (60).

FIGS. 6a-b illustrate an exemplary embodiment of the present teachingswhere a plication lock delivery system (100) is set to deliver a suturelock assembly (20). In some embodiments of the present teachings, inorder to prevent movement of the lock pin (32) and lock body (30)relative to the inner catheter (46) as the plication lock deliverysystem tracks through tortuous paths inside a body, the plication lockdelivery system (100) is put in a pre-load configuration during apercutaneous delivery. In such a pre-load configuration, an outer sheath(48) with lock pin (32) engaged at its tip is configured to resistdistal push by the inner catheter (46). One skilled in the art shouldunderstand that mechanisms other than what is described in detailsherein can be incorporated to achieve this purpose. What has beendisclosed below is merely exemplary non-limiting embodiments.

FIG. 6b illustrates an exemplary embodiment of the pre-loadconfiguration where a lock pin (32) is retained at the proximal end of aslot (38) on a lock body (30) of the present teachings during apercutaneous advancement. In one exemplary embodiment of the presentteachings, the distal end portion of an outer sheath (48) can beincorporated in a “J-shaped” slot (55), so that a distal push by theinner catheter (46) will trap the lock pin (32) inside the upward tip(59) of the slot (55). In this embodiment, the outer sheath (48)provides a proximal resistance to the inner catheter (46), preventingthe inner catheter (46) from deforming longitudinally. As the exemplaryplication lock delivery system (100) tracks around curves inside thebody, when the inner catheter (46) starts to deform longitudinally withthe lock pin (32) trapped inside the J slot (55), the outer sheath (48)resists the distal push of the inner catheter (46). Although not shownin FIG. 6b , during such an exemplary advancement, the pull wire (50) ispulled proximally in order to maintain the contact between the innercatheter (46) and the lock assembly (20). In an exemplary embodiment ofthe present teachings where a tissue plication lock delivery system(100) is in the pre-load configuration, the inner catheter (46) iscompressed by the outer sheath (48), the outer sheath (48) is in tensionby the inner catheter (46). In some embodiments, as shown in FIG. 6a , apre-load cam (66) can be activated on the control assembly (60) of theplication lock delivery system (100) in order to switch the plicationlock delivery system (100) from other configurations to the pre-loadconfiguration and provide ease of use to a clinician. In otherembodiments of the present teachings, other mechanisms can beincorporated to achieve the pre-load configuration. In yet otherembodiments, a pre-load configuration is not required for tissueplication.

In various embodiments, before advancing a plication lock deliverysystem (100) of the present teachings inside a body, a suture threader(102) is loaded inside the plication lock delivery system (100) tocapture sutures. As shown in FIG. 7a , the suture threader (102) has adistal loop (104) for sutures to slide through, an elongated body (105),and a proximal tab (106) for ease of handling by a clinician. In someembodiments, a clinician loads sutures threader (102) to the plicationlock delivery system (100) by inserting a suture threader (102) insidethe suture port (62) on the control assembly (60), extending suturethreader (102) distally through the suture lumen in the inner catheter(46), continue distally through the lumen (26) of the lock assembly(20), with the distal loop (104) of the suture threader (102) coming outof the distal end (22) of the lock assembly (20), and the proximal tab(106) of the suture threader (102) remains partially inserted insidesuture port, as illustrated in FIGS. 6a-b . In other embodiment, theplication lock delivery system (100) is pre-packaged with suturethreader (102) already loaded. A clinician then load sutures (16, 18) tothe plication lock delivery system (100) by first inserting the sutures(16, 18) through the distal loop (104) of the suture threader (102) asillustrated in FIG. 7b , then pulling the suture threader tab (106)proximally allowing the suture threader (104) sliding distally throughthe suture lumen of the inner catheter (46) carrying sutures (16, 18).In some embodiments, as the suture threader (102) is pulled proximally,the sutures (16, 18) enter the distal end (22) of the lock assembly(20), travel through the lock body lumen (26), exit at the proximal end(24) of the lock body (30), enter the distal end (45) of the innercatheter (46), travel along the suture lumen of the inner catheter (46),exit at the proximal end of the suture lumen, reach the control assembly(60) at the proximal end of the inner catheter (46), and exit at thesuture port (62) on the control assemble (60). Upon completion of such asuture threading, as illustrated in FIG. 8a , two proximal end portionsof the sutures come out of the suture port (62) on the control assembly(60). FIG. 8b illustrates the lock assembly (20) and distal end portionof the catheter assembly (40) where two sutures (16, 18) are loadedinside and extend through the distal opening of the lock (20).

Referring back to FIG. 7a , in one exemplary embodiment, the distal loop(104) of the suture threader (102) includes a twist resulting general a“8”-shaped loop, with a smaller loop (107) at the distal end of the loop(104). This configuration, for example, allows the suture threader (102)to secure the sutures (16, 18) during threading and/or pulling. Forexample, when the suture threader (102) is pulled proximally, thesutures (16, 18) are pushed into the smaller distal loop (107) toprevent them from coming loose. In one embodiment, the twist ranges from90°-360°.

In various embodiments, if one or both sutures is lost during theinitial threading, the suture threader (102) can be reloaded into theplication lock delivery system (100) to repeat the threading step. Insome embodiments, without activating the pre-load cam (66) on thecontrol assembly, a suture threader (102) is prevented from beingpulling proximally. In other embodiments, the plication lock deliverysystem (100) is pre-packaged with the suture threader (102) pre-loadedand the pre-load cam deactivated. In yet other embodiments of thepresent teachings, a suture threader is operated independently from thepre-load cam mechanism.

In various embodiments, a complete assembly, including a plication lockdelivery system (100) and sutures (16, 18) loaded inside, is advanced tothe treatment location by sliding inside a guide catheter placed insidea delivery track inside the body. In other embodiments of the presentteachings, the system is advanced to a treatment location by trackingover the sutures (16, 18) enclosed within including a plication lockdelivery system (100).

FIG. 9b illustrates an embodiment of the present teachings where thedistal end portion of an exemplary assembly reaches the mitral valveannulus (10) and two pledgets (12, 14) have been implanted. Satisfiedwith the location, a clinician can now apply tension to the sutures (16,18). Referring to FIG. 9a , a suture is shown to be loaded into anexemplary suture tension mechanism (64). According to variousembodiments of the present teachings, the suture tension mechanism (64)includes a first suture clamp (63) and a tension means (65). In someembodiments, upon securing a first suture to the first suture clamp(63), a clinician activates the suture tension means (65) to applytension to the first suture (e.g., by rotating a knob or the like). Insome embodiments of the present teachings, a clinician aligns the lockassembly (20) to a pledget by applying tension to a suture extendingfrom this pledget. In other embodiments, a clinician aligns the lockassembly (20) to one pledget by applying tension to a suture extendingfrom the other pledget. In other embodiments, a clinician aligns thelock assembly (20) between the pledgets by applying tension to either ofthe two sutures (16, 18) extending from the two pledgets. In otherembodiments of the present teachings, a first clutch mechanism (notshown) is incorporated in the control assembly (60) of the plicationlock delivery system (100) so that as the tension on the suture reachesa certain level, such as 0.75 lb, the clutch mechanism (100) isactivated to prevent the suture from being stretched beyond its limit.It should be understood by those skilled in the art that although aclamp (63) and a knob means (65) is shown in FIG. 9a , other designs canalso be used here.

Now referring to FIG. 9c , in various embodiments, while maintaining thetension on the first suture, a second suture is loaded into a tissueplication mechanism (68) and tension is applied to the second suture toplicate tissues. Similarly, according to some embodiments of the presentteachings, the tissue plication mechanism (68) includes a second sutureclamp (67) and a tissue plication means (69). In some embodiments, uponsecuring the second suture to the second suture clamp (67), a clinicianactivates the tissue plication means (69) which applies tension to thesecond suture. FIG. 9d illustrates tissues being plicated according toone embodiment of the present teachings. In some embodiments of thepresent teachings, a second clutch mechanism (not shown) is incorporatedin the control assembly (60) so that as the tension on the second suturereaches a certain level, such as 5 lb, the clutch is activated toprevent the second suture from being stretched beyond its limit. Inother embodiments, the degree of the tension applied to the suture canbe determined by visualizing the amount of plication applied to thetissue, for example, fluoroscopically. Additionally, it should beunderstood by those skilled in the art that although a clamp and a knobmeans is shown in the drawing, other design can also be used.

In various embodiments of the present teachings, while the tissueplication mechanism (68) tensions the second suture, the first suture isprevented from coming loose by further activating the suture tensionmechanism (64). In some embodiments, tension applied on one or bothsutures can be released, for example, by activating a release button. Insome embodiments, one or both sutures can be re-tensioned again.

In various embodiments of the present teachings, tension is applied toone or both sutures by spooling around a suture clamp (63, 67) which iscoupled to an actuator, such as a knob, that can be manipulated by theuser. In other embodiments of the present teachings, tension is appliedto one or both sutures by linearly pulling on a suture clamp (63, 67) ordrawing tension on sutures engaged between pinch rollers. Othermechanisms can also be used to apply tension to the suture.

In various embodiments, after a clinician is satisfied with the extentof the tissue plication, the lock assembly (20) is deployed. FIGS. 10a-billustrate an embodiment of the lock deployment of the presentteachings. In this embodiment, the lock deploy-and-release mechanism(70) includes a lockout button (71), an indicator (72), and adeploy-and-release means (74). The lockout button (71) can be used toprevent an accidental activation of the lock deploy-and-releasemechanism (70). In some embodiments of the present teachings, withoutsetting off such a lockout button (71), a clinician is prevented fromactivating the deploy-and-release means (74). The indicator (72) canprovide a visual aid for the lock deployment and releasing process.Additionally, it should be understood by those skilled in the art thatalthough a button design for the lockout (71), a fin design for theindicator (72), and a knob design for deploy-and-release means (74) isshown in the drawing, other designs and configurations of the lockdeployment and release mechanism (70) can also be used. In someembodiments, a lockout function is eliminated or combined with thedeploy-and-release means (74). In other embodiments, one or both of thelock out and indicator are not included in the lock deploy-and-releasemechanism (70).

In various embodiments, to deploy the lock assembly (20), a clinicianfirst initiates the lockout button (71) and activates thedeploy-and-release means (74). In some embodiments, the lockdeploy-and-release mechanism (70) pulls the pull wire (50) proximallyrelative to the outer sheath (48), which in turn pulls the lock body(30) proximally relative to the outer sheath (48). In certainembodiment, the lock pin (32) is pushed distally by the distal end ofthe outer sheath (48) to secure the sutures (16, 18) inside the lockassembly (20). In other embodiments, the lock deploy-and-releasemechanism (70) pushes the outer sheath (48) distally while maintainingthe pull wire (50) and the lock pin (32) is then pushed distally by thedistal end of the outer sheath (48) to secure the sutures (16, 18)inside the lock assembly (20). In yet other embodiments of the presentteachings, the lock deploy-and-release mechanism (70) pulls the pullwire (50) proximally and pushes the outer sheath (48) distally at thesame time and the lock pin (32) is then pushed distally by the distalend of the outer sheath (48) to secure the sutures (16, 18) inside thelock assembly (20). FIG. 10b illustrates an embodiment of the presentteachings, where sutures (16, 18) are secured by and located inside thelock assembly (20). As illustrated in FIG. 10b , during an exemplarylock deployment, the pull wire (50) remains threaded through a sideopening (37) of the lock assembly (20) and is prevented from comingloose by the distal post (43) on the inner catheter (46).

In various embodiments of the present teachings, as illustrated in FIG.10a , the indicator (72) of the lock deploy-and-release mechanism (70)moves from its first state to a second state, indicating the completionof a lock assembly (20) deployment.

In various embodiments of the present teachings, as shown in FIG. 10c ,a drive rack (76) is connected with the lock deploy-and-release means(74), the pull wire (50), and an outer sheath (48). In some embodiments,upon activating the deploy-and-release means (74), the drive-rack (76)is pulled proximally, which pulls the pull wire (50) proximally withoutaffecting outer sheath (48). In other embodiments of the presentteachings, a drive gear (77) is connected to the drive-rack (76) suchthat, upon activating the deploy-and-release means (74), the drive gear(77) causes a distal motion to the outer sheath (48) without affectingthe pull wire (50). In other embodiments of the present teachings, uponactivating the deploy-and-release means (74), the drive-rack (76) ispulled proximally, which pulls the pull wire (50) proximally and pushesthe outer sheath (48) distally at the same time. Although an exemplarydrive-rack (76) and an exemplary drive gear (77) are disclosed here, oneskilled in the art should appreciate that other mechanisms can beincorporated to achieve the same functions and obvious variationsthereof. In one embodiment, the lock assembly deployment is an automaticprocess, such that activating a spring can complete the travel of adrive rack.

In various embodiments, the deployment of a lock assembly (20) of thepresent teachings is measured by the travel distance of the pull wire(50) and outer sheath (48). In some embodiments, the travel distance isabout 10-30 mm. In other embodiments, the deployment of a lock assembly(20) can be measured by the counter force received by thedeploy-and-release means (74). For example, the distal travel by thelock pin (32) generates a greater counter force to the control assembly(60) as the sutures (16, 18) being compressed than before the sutures(16, 18) being compressed. In yet other embodiments, the deployment ofthe lock assembly (20) is monitored by changes in an indicator (72) onthe control assembly (60).

In various embodiments, after sutures (16, 18) are secured by a lockassembly (20), the lock deploy-and-release means (74) stops the motionof the pull wire (50) and/or outer sheath (48), so that the pull wire(50) no longer restricts the distal movement of the lock body (30),and/or the outer sheath (48) no longer restricts the proximal movementof the lock pin (32). In various embodiments, at this time, the tensionapplied in the control assembly (60) on both sutures can be released,either with the sutures remaining inside the suture clamps (63, 67) orwith the sutures (16, 18) released from the suture clamps (63, 67). Invarious other embodiments of the present teachings, the tension on thesutures (16, 18) is released automatically at the end of the lockassembly (20) deployment. At this time, a clinician can assess the lockdeployment before the final release. In some embodiments, the indicatorof the deployment release mechanism indicates the completion of a lockdeployment step.

To release the lock assembly (20), in various embodiments, thedeploy-and-release mechanism (70) is further activated, for example, bycontinuously activating the deploy-and-release means (74). In variousembodiments, the deploy-and-release means (74) pulls the inner catheter(46) proximally relative to the pull wire (50), releasing the distalpost (43) of the inner catheter (46) from the blind hole (35) of thelock body (30) and the distal loop (52) of the pull wire (50), freeingthe pull wire (50) from the side opening (37) of the lock body (30). Atthis point in these embodiments, the lock assembly (20) is disconnectedfrom the inner catheter (46) and the catheter assembly (40). In someembodiments, to remove the catheter assembly (40) from the body, twosutures (16, 18) are first released from the two suture clamps (63, 67)if a clinician has not already done so and the plication lock deliverysystem (100) is retracted out of the body, leaving behind the lockassembly (20) clamping on two sutures (16, 18). FIG. 11a illustrates anembodiment of the present teachings where the lock assembly (20) isreleased from the inner catheter (46) and catheter assembly (40).

In various embodiments of the present teachings, as illustrated in FIG.11b , the indicator (72) of the lock deploy-and-release mechanism (70)moves from its second state to a third state indicating the completionof a lock assembly (20) releasement.

To further remove excess sutures in some embodiments, a suture cutter isadvanced proximally to the lock and cuts the sutures. Both the suturecutter and the excess sutures can then be removed. One skilled in theart should understand that a variety of suture cutter designs can beused to remove the excess sutures. In addition, U.S. patent applicationSer. No. 11/935,054, entitled “Suture cutter and method of cuttingsuture,” filed Nov. 5, 2007, is incorporated herein by reference in itsentirety.

FIG. 12 illustrates an exemplary design of a control assembly (200)according to one embodiment of the present teachings. One skilled in theart should understand that other designs can also be used to achieve thefunctions described above and obvious variations thereof. Thus, what isillustrated and explained herein should not be construed as limiting. Inthis exemplary embodiment, the control assembly (200) includes a housing(202 a, 202 b). In some embodiments, the housing (202 a, 202 b)accommodates a suture tension mechanism, a tissue plication mechanism,and/or a lock deploy-and-release mechanism. In some embodiments, thehousing (202 a, 202 b) also accommodates a suture port (204), a pre-loadcam (206), a tension releasing means (208), and/or other parts ormechanisms.

In various embodiments, a pre-load cam is configured to have a ramp sothat once the pre-load cam (206) is activated, it pushes the innercatheter distally while the pull wire and/or the outer sheath remainsteady. As described above, in some embodiments, during pre-loadconfiguration, an inner catheter of a catheter assembly is compressed byan outer sheath and the outer sheath is in tension by the innercatheter. In one embodiment, before activation, the pre-load cam (206)also functions to latch a suture threader in place. In certainembodiments, activating the pre-load cam also frees the suture threaderand allow a suture to be threaded.

In various embodiments, a suture tension mechanism includes at least oneof a top suture clamp (210 a), a bottom suture clamp (210 b), a clampgear (218), a suture tension means (214), a suture tension gear (216),and a suture tension clutch (212). In some embodiments, once a suture isclamped between the top suture clamp (210 a) and the bottom suture clamp(210 b), a clinician starts the suture tension means (214) (rotatableknob), which engages and activates the suture tension gear (216). Incertain embodiments, both the suture tension gear (216) and clamp gear(218) are connected to a center gear stack (220 a, 220 b) with a topgear (220 a) and a bottom gear (220 b). In certain embodiments, themotion of the suture tension gear (216) sets off a motion of the bottomgear (220 b) of the center gear stack (220 a, 200 b), which in turn setsoff the clamp gear (218). In certain embodiments, the motion of theclamp gear (218) allows a suture to be wrapped around the suture clamp(210 a, 210 b). In certain embodiments, a suture tension clutch (212)connected to the suture clamp (210 a, 210 b) is activated when apre-defined tension is reached to prevent from over tensioning to thesuture.

The suture clamps (210 a, 222 a) can include hinged lids that allow theuser to observe and make sure that the suture is properly clamped to theclamp part. After the clamping is done, the lid is closed.

In various embodiments, a tissue plication mechanism includes at leastone of a top suture clamp (222 a), a bottom suture clamp (222 b), aclamp gear (226), a tissue plication means (rotatable knob) (225), atissue plication gear (228), and a tissue tension clutch (224). Invarious embodiments, once a suture is clamped between the top sutureclamp (222 a) and bottom suture clamp (222 b), a clinician starts thetissue plication means (225), which engages and activates the tissueplication gear (228). In some embodiments, both the tissue plicationgear (228) and clamp gear (226) are also connected to a center gearstack (220 a, 220 b). In some embodiments, the motion of the tissueplication gear (228) sets off a motion of the top gear (220 a) of thecenter gear stack (220 a, 200 b). In some embodiment, the top gear (220a) of the center gear stack (220 a, 220 b) drives both the bottom gear(220 b) and the clamp gear (226). In some embodiments, the motion of theclamp gear (226) allows a suture to be wrapped around the suture clamp(222 a, 222 b) and the bottom gear (220 b) drives the suture tensiongear (216) to prevent the other suture from losing its tension duringtissue plication process. In certain embodiments, the suture tensionclutch (224) connected to the suture clamp (222 a, 222 b) is activatedwhen a pre-defined tension is reached, thereby preventing from overtensioning to the suture.

In various embodiments, a tension releasing means (208) is incorporatedto reverse the suture tension. For example, a tension releasing means(208) pushes down the center gear stack (220 a, 220 b) so that clampgears (226, 218) are freed. While no longer being strained, the suturescontract to lose its tension.

In various embodiments, a lock deploy-and-release mechanism includes atleast one of a lock deploy-and-release means (230), a lead screw (232)connecting the lock deploy-and-release means (230), and a drive rack(234). During an exemplary lock assembly deployment, as the a lockdeploy-and-release means (230) sets off, the lead screw (232) turns andthe drive rack (234) pulls the pull wire (50) proximally since it isoperatively coupled thereto. The motion of the drive rack also sets offa main drive gear (236), which then pushes the push arm (240) distally.The push arm (240) connects the proximal end of the outer sheath (48). Adistal motion on the push arm will then drive outer sheath distally.

In various embodiments, a control assembly includes a pull wire claspassembly (238). The pull wire clasp assembly (238), as illustrated inFIG. 13, includes at least one of a clasp body (241), a barrel screw(242), a proximal spring (244), a distal spring (246), and a flat steelclasp (248). Referring to the embodiments illustrated in FIG. 13, thebarrel screw (242) is threaded through the two springs (244, 246), theflat steel clasp (248), and the clasp body (240). In some embodiments,the distal end (250) of the barrel screw (240) connects the pull wire,for example, by thread or other means. A clasp (248) can include a holewhich is able to slide over the barrel screw (242). The distal spring(246) can in turn slide over the barrel screw (242) and be positioned sothat the spring (246) is compressed slightly, thereby pushing on theclasp (248) and causing it to cantilever relative to the barrel screw(242). In some embodiments, the proximal spring (244) slides over thebarrel screw (242) and pushes proximally on the proximal end (252) ofthe barrel screw (242).

According to various embodiments of the present teachings, the claspassembly (238) serve one or more functions. For example, the internalthreads allow for enough adjustability of the pull wire (50) to theclasp assembly (238) joint to ensure that the relative lengths of theinner catheter (46) and pull wire (50) are always normalizedappropriately for assembly. For example, the proximal spring (244),which pushes with a load on the barrel screw (242), ensures that thepull wire is always under a predetermined load during packaging andhandling of the device. For example, the compressed proximal springs(244) take up any pull wire slack that may occur during normal use ofthe plication and lock delivery system and makes sure that the pull wireis always under some predetermined minimum amount of tension so thatlock assembly is not released prematurely. The pull wire clasp assemblycan be used as a one-way clasp. In some embodiments, a flat steel clasp(248) component, which is biased by a distal spring (246), allows thebarrel screw (242) to migrate proximally, but locks any proximal motionin place. In these embodiments, the flat steel clasp (248) componentcompletely prevents any distal migration of the barrel screw (242). Insome embodiments, the locking feature of the clasp functions because thecantilevered nature of the clasp and the tightly controlled diameter ofthe hole in the clasp conspire to create a jamming effect when tensionis apply distally to the barrel screw (242). For example, the higher isthe distal tension force on the barrel screw (242), the morecantilevered becomes the flat steel clasp (248) and the harder it bindson the barrel screw (242).

In various embodiments, after a predetermined distance, for example,about 5 mm, of the lock deployment (measured by the travel distance ofdrive rack), the inner catheter is released, for example, by releasing apre-load keeper (231), such that the inner catheter does not restrict aproximal movement of the lock body.

In various embodiments, the total drive rack motion given to a lockassembly deployment is approximately 18 mm. After this distance, forexample, a pull wire clasp assembly (238) engages into a stationaryalcove so that it is not pulled any father. At approximately the sametime, the drive rack (234) can disengage from the drive gear (236) (bydisengagement of teeth of the rack from teeth of the gear) and allow theouter sheath push arm (240) to return to the unload position and releasethe load on the outer sheath. The alcove is formed within an undersideof the housing (202 b). The pull wire clasp assembly (238) is receivedwithin a track formed in the drive rack (234) and as the drive rack isdriven, the pull wire clamp assembly (239) is carried by the drive rack(234). In FIG. 12, the track is shown directly below the assembly (238).Once the clasp assembly (238) is in registration with the alcove, theassembly (238) is received into the alcove and thereby is disengagedfrom the rack (234). The drive rack (234) can continue to movelongitudinally without carrying the clasp assembly (238).

In various embodiments, when a lock assembly deployment is completed, aramp on the drive rack (234) is pushed down on the suture lease buttonto cause the tension on both the sutures to be released. In someembodiments, after all of the tension is released, the drive rack (234)engages with the inner catheter hub and the remainder of the travel isused to pull the inner catheter proximally. This motion can pull thedistal post of the inner catheter out of the lock body and allow thepull wire to be released from the lock body. At this point, the catheterassembly is no longer attached to the lock assembly and can be removedfrom the body.

While the devices are discussed at length for being used to plicate amitral valve annulus and deliver a plication lock, it should beunderstood and appreciated that the devices of the present teachings canbe used in other applications related and unrelated to the mitral valverepair. For example, some embodiments of the present teachings can beused to close and secure an unwanted opening in a tissue in the body,such as the stomach, and to repair another dysfunctional valve in theheart, such as the tricuspid valve.

The control system (60) of the present invention thus allows the user toperform a number of different operations. For example and as describedherein, in a pre-load position, the sutures can pass through thecatheter lumen and through the lumen (26) of the lock body (30) and arenot locked in place. The loop (52) at the end of the pull wire (50) isdisposed around the protrusion (43) which itself is disposed withinblind hole (35), thereby coupling the inner catheter to the lock body.The ends of the pin (32) are received within the slots (J shaped) (55)formed within the interior of the outer catheter (48), thereby couplingthe lock body (30) to the outer catheter. In this position, the pullwire (50) can move separate and independent from the inner catheter (46)(i.e., the pull wire 50 can be pulled as by action at the control systemto cause longitudinal movement thereof (i.e., pull wire (50) can bepulled). As described herein, the user uses the control system (60) toapply tension to the sutures (16, 18) as part of a tissue plicationstep. This is done using the respective controls that are part of thecontrol mechanism (60). As described, to lock the locking body, themechanism (70) is rotated and this causes the pull wire (50) to move ina proximal direction (toward the mechanism 70) and since the pull wireloop is engaged with the post (43), the inner catheter (46) likewisemoves proximally. Simultaneously, this user action results in the outercatheter (48) being driven distally. These two key parts (assemblies)are thus moving in opposite directions resulting in the pin (32) movingwithin slot (38) (and moving within the slot (55) into a lockingposition in which the pin (32) contacts and pinches the sutures (16, 18)to lock them in place. Further manipulation (further rotation) at thecontrol system (70) results in the undocking of the inner catheter (46)from the lock body (30) as a result of the post (43) disengaging fromthe blind hole (35). This action allows the loop (52) and pull wire (50)to be pulled from the side channel (37) since the post (43) no longerpasses through the loop (52). Also, the pin (32) continues to move inthe slot (55) and slides laterally and disengages from the slot (55),thereby disengaging the lock body from the outer catheter, while stillmaintaining a lock of the sutures (16, 18) due to the location of pin(32) in the slot (38). The lock assembly (20) is thus released and leftat the site with the sutures locked in place.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art. Methods and materials similar or equivalent to those describedherein can be used in the practice or testing of the present teachings.In case of conflict, the patent specification, including definitions,will control. In addition, the materials, methods, and examples areillustrative only and not intended to be limiting.

We claim:
 1. A plication lock delivery system for creating a tissueplication comprising: a lock assembly comprising a lock body and a lockpin, wherein the lock body has a central lumen configured to retain thelock pin and to have a first and a second sutures disposed within thecentral lumen; a catheter assembly comprising an outer sheath and aninner catheter, wherein the inner catheter has a distal end, a proximalend, and a central lumen, wherein the distal end of the inner catheteris configured to detachably connect to the lock body, wherein thecentral lumen is configured to have the first and the second suturesdisposed within, wherein the outer sheath has a distal end and aproximal end, wherein the distal end is configured to contact the lockpin and cause movement thereof; and a control assembly comprising afirst suture tension mechanism configured to apply tension to a firstsuture, a second suture tension mechanism configured to apply tension toa second suture, and a lock deploy-and-release mechanism configured tosecure the first and the second sutures to the lock assembly and torelease the lock assembly from the catheter assembly at a target site;wherein the control assembly is operatively coupled to the proximal endsof the outer sheath and inner catheter.
 2. The system of claim 1,wherein the lock body further includes a first locking slot formedtherein and extending along a longitudinal length thereof, the firstlocking slot intersecting the central lumen in which the first andsecond sutures are located, the lock body further including a sideopening that is open along a side thereof and communicates with thecentral lumen and a second opening that is open at a proximal end of thelock body, the second opening being spaced and separate from thelongitudinal lumen however the side opening intersects and passesthrough the second opening.
 3. The system of claim 2, further includinga locking pin that extends through the first locking slot with ends ofthe locking pin being disposed outside of the lock body, the ends beingreceived, in certain operating positions, in a complementary secondlocking slot that is formed along the inner surface of the outer sheath,thereby coupling the lock body to the outer sheath.
 4. The system ofclaim 3, wherein the inner catheter includes a post that extendsoutwardly from the distal end of the inner catheter, the post beingreceived within the second opening for detachably connecting the innercatheter to the lock body.
 5. The system of claim 4, further including apull wire that is operatively connected at a proximal end to the controlassembly such that the pull wire can be controllably pulled in aproximal direction by operation of the control assembly and independentfrom longitudinal translation of the inner catheter, the pull wirehaving a loop formed at a distal end thereof, wherein the loop isdisposed within the side opening with the post passing through anopening of the loop when the lock body is connected to the innercatheter.
 6. The system of claim 5, wherein the control system isconfigured such that actuation of the lock deploy-and-release mechanismcauses the pull wire to be pulled in a proximal direction resulting inproximal translation of the inner catheter.
 7. The system of claim 5,wherein the lock deploy-and-release mechanism includes an actuator thatis accessible to and manipulated by the user, the actuator beingoperatively connected to a drive rack that is operatively connected tothe pull wire and being operatively coupled to a drive gear which iscoupled to a push arm which is coupled to a proximal end of the outersheath, wherein activation of the actuator causes the drive rack to bedriven in a first direction resulting in the pull wire being pulled in aproximal direction and the outer sheath being driven in a distaldirection as a result of the push arm being driven distally by rotationof the drive gear.
 8. The system of claim 7, further including a pullwire clasp assembly including a clasp body to which the pull wire isattached, the pull wire clasp assembly being coupled to the drive racksuch that longitudinal translation of the drive rack causes longitudinaltranslation of the pull wire clamp assembly.
 9. The system of claim 8,wherein the drive rack has a maximum degree of travel and whereuponprior to the drive rack reaching one end of the maximum degree oftravel, the pull wire clasp assembly engages into a stationary alcovewhich prevents any further longitudinal movement of the pull claspassembly and the drive rack is configured such that the drive rackdisengages from the drive gear, thereby allowing the outer sheath toreturn to an unload position.
 10. The system of claim 9, wherein thestationary alcove is formed in an underside of a housing of a handlestructure which contains the control system, whereupon once the pullclasp assembly is located in the stationary alcove, the longitudinaltranslation of the pull wire is completed, while the drive rack ispermitted to be further driven in a longitudinal direction.
 11. Thesystem of claim 9, wherein the stationary alcove is located at aposition and teeth formed along the drive rack are configured such thatat approximately the same time that the pull clasp assembly enters andis held within the stationary alcove, the drive rack disengages from thedrive gear.
 12. The system of claim 1, wherein each of the first andsecond suture tension mechanisms includes a suture clamp device to whichthe respective suture is attached; a suture tensioning actuator which iscoupled to a suture tension gear which is also coupled to the sutureclamp device such that operation of the suture tensioning actuatorcauses rotation of the suture tension gear and rotation of the sutureclamp device resulting in a winding of the suture about the suture clampdevice and tension being applied to the suture.
 13. The system of claim12, wherein each suture tension mechanism includes a clutch that isoperatively connected to the suture clamp device such that once apredefined tension in the suture is achieved, the clutch is activated toprevent the suture from being over tensioned.
 14. A method of deliveringa lock assembly percutaneusly comprising: providing a lock deliverysystem with a lock assembly, a catheter assembly comprising a distal endand a proximal end, and a control assembly, wherein the lock assembly isconfigured to secure at least one suture, the distal end of the catheterassembly being configured to connect the lock assembly, and the controlassembly being configured to connect the proximal end of the catheterassembly, to apply tension to the at least one suture, to activate thesecuring of the at least one suture to the lock assembly, and to releasethe lock assembly; extending the at least one suture through the lockassembly; extending the at least one suture from the distal end to theproximal end of the catheter assembly; joining the at least one sutureto the control assembly; applying tension to the at least one suture;secure the tensioned suture to the lock assembly; and releasing the lockassembly from the catheter assembly.
 15. A method of plicating a tissueand securing the tissue plication with a lock assembly percutaneuslycomprising: providing a plication lock delivery system with a lockassembly, a catheter assembly comprising an outer sheath and an innercatheter, and a control assembly, wherein the lock assembly comprises alock body and a lock pin, wherein the lock body has a central lumenconfigured to retain the lock pin and have a first and a second suturesdisposed within, the inner catheter having a distal end, a proximal end,and a central lumen, and wherein the distal end of the inner catheter isconfigured to connect the lock body, the central lumen being configuredto have the first and a second sutures disposed within, and the outersheath having a distal end configured to contact the lock pin and aproximal end; and wherein the control assembly connects the proximalends of the outer sheath and inner catheter and comprises a first suturetension mechanism configured to apply tension to the first suture, asecond suture tension mechanism configured to apply tension to thesecond suture, and a lock deploy-and-release mechanism configured tosecure the first and the second sutures to the lock assembly and torelease the lock assembly inside the body; extending the first andsecond sutures through the lock assembly; extending the first and secondsutures from the distal end to the proximal end of the catheterassembly; applying tension to the first suture with the first suturetension mechanism of the control assembly; applying tension to thesecond suture with the second suture tension mechanism of the controlassembly; securing the first and the second sutures to the lock assemblywith the lock deploy-and-release mechanism of the control assembly; andreleasing said lock assembly from the catheter assembly.